Medicaid Incentives for the Prevention of Chronic Diseases: Diabetes Prevention (MIPCD)

May 1, 2017 updated by: University of Pennsylvania
The relative effectiveness of incentives based on process (e.g. medication adherence) vs. outcome (improvements in blood pressure) is unknown, leading to the key research question: Which approach is more effective? The incentive structure for this initiative is based on best practices in the use of process and outcome measures to address this fundamental question. A series of incentive designs will be conducted to examine the relative effectiveness of equivalent value incentives based on process (e.g. attending smoking cessation counseling sessions), outcomes (e.g. quitting smoking), or a combination of process and outcomes incentives (e.g. attending smoking cessation counseling sessions and quitting smoking). This will also provide an overarching framework for assessing the relative importance of process versus outcome incentives in different contexts and for different populations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although great potential exists to promote healthy behaviors through financial incentives, few studies have compared the efficacy and effectiveness of incentives in a Medicaid population. This is important because although financial incentives structured as rewards to individuals substantially improve rates of healthy behaviors, the absolute proportions of people adopting healthier behaviors remain low. Early approaches to financial incentives generally have reflected all-or-nothing thinking by showing that providing incentives is better than not providing incentives, and by assuming that incentives will work similarly across different types of people. But basic research in behavioral economics suggests that how you pay and whom you pay may be critical factors. Furthermore, the relative effectiveness of incentives based on processes vs. outcomes is unknown, and indeed, is one of the most fundamental unresolved questions in the incentive literature. Economists would argue that outcome-based incentives are likely to be more effective because they allow each person to figure out the most efficient path to achieve a desired result. On the other hand, behavioral economists would argue in favor of incentivizing processes because they are simpler and more concrete. Additionally, some ethicists argue that incentivizing processes is fairer because they are effort dependent, and because in some cases the ability to achieve improvements in outcomes may be related to factors people cannot control, such as their environment or their genes. Ultimately, the key question from a health and economic policy standpoint is which approach is more effective. In this regard, improvements in outcomes seem appropriate to incentivize directly because such results are required for incentive programs or other interventions to improve health and/or reduce health care spending. And indeed, there is some limited evidence suggesting that incentives for weight loss, for example, may be more effective than incentives for process measures (eg, attendance) in obesity programs.

The goal of the New York State Medicaid Incentives Plan is to improve clinical outcomes and decrease health expenditures by increasing smoking cessation, lowering high blood pressure, preventing diabetes onset, and enhancing diabetes self-management among Medicaid enrollees in New York State. Several incentive strategies will be explored to promote the use of under-utilized Medicaid benefits and regional resources. The New York State (NYS) Medicaid Incentives Program will target four prevention goals: 1) smoking cessation; 2) lowering high blood pressure; 3) diabetes onset prevention; and 4) diabetes management. For each prevention goal, four treatment arms have been defined. One treatment arm will receive incentives for process activities; one treatment arm will receive incentives for achieving desired outcomes; one treatment arm will receive incentives for both process activities and outcomes; and one arm will serve as a control, receiving no incentives. The smoking cessation incentive program will be piloted in western New York where smoking rates are higher than other regions of the state. Participants will receive direct cash payments for participating in smoking cessation counseling (process), filling nicotine replacement therapy prescriptions (process), and quitting smoking (outcome). 2,332 participants will be recruited for this study. The blood pressure control incentive program will be piloted in New York City where stakeholders are highly engaged and a large population of people at risk for inadequate blood pressure control reside. Participants will receive direct cash payments for attending primary care appointments (process), filling antihypertensive prescriptions (process), and decreasing or maintaining a decreased systolic blood pressure by 10mmHg or achieving another clinically appropriate target (outcome). 488 participants will be recruited for this study. The diabetes management incentive program will be piloted in New York City where the capacity of diabetes self management educators is the greatest. Participants will receive direct cash payment for attending primary care appointments (process), attending diabetes self-management education sessions (process), filling diabetes prescriptions (process), and decreasing their HbA1c by 0.6% or maintaining a level of 8.0% or less (outcome). 660 participants will be recruited for this study. The diabetes onset prevention incentive program will be piloted in western New York and New York City, where the capacity of YMCA Diabetes Prevention Programs is the greatest and well-integrated with stakeholders. Participants will receive lottery tickets for attending YMCA Diabetes Prevention Program sessions (process) and losing or maintaining a reduced weight (outcome). 596 participants will be recruited for this study. Other incentive approaches and research questions will be explored through rapid cycle evaluation.

Study Type

Interventional

Enrollment (Actual)

596

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12201
        • NYS Department of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Have been diagnosed as pre-diabetic or high risk for diabetes
  • Had a HbA1c test in the last year and if not are willing to get one now
  • Medicaid enrolled in NYS

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Process incentives
Process incentives participants will receive incentives based on visit attendance in the YMCA DPP session. This incentive will be $ 15 for attending each session.
Behavioral: Process incentives
Participants will receive cash based incentives for achieving process based measures (class attendance).
Experimental: Outcome incentives
Outcome incentives participants will be weighed at 8 and 16 weeks after the program starts and if they have lost 2.5% of their body weight at each time point then they will receive $100 and $140 respectively.
Behavioral: Outcome incentives
Participants will receive cash based incentives for outcome based measures (weight loss).
Experimental: Process and Outcome incentives
If assigned to the Process and Outcome arm participants will be informed that they can earn additional incentives for attending DPP classes and losing weight. Participants in this arm can earn $7.50 per DPP class (max 16) and $50 and $70 for achieving 2.5% weight loss at 8 and 16 weeks respectively.
Behavioral: Process and Outcome incentives
Participants will receive cash based incentives for both achieving process based measures (class attendance) and outcome based measures (weight loss).
No Intervention: Control arm
If assigned to the Control arm participants will not be eligible for any additional incentives and will just learn the goals of the DPP program itself.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process measure: measurement of activities related to diabetes prevention (attending DPP class attendance
Time Frame: During a 16 week program once enrolled
Number of completed education sessions in a16-week DPP program
During a 16 week program once enrolled
Outcome measure: Measure of decrease in weight loss across 16 weeks
Time Frame: During a 16 week period once enrolled
Weight loss during program.
During a 16 week period once enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

New York State Department of Health
Centers for Medicare and Medicaid Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 818842-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Prevention

Clinical Trials on Process incentives

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe